TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients

NCT01090648 | Completed Phase 1

• 1 other identifier: CR017038
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.

Conditions

HIV-Infections

Keywords

TMC125HIV1083; TMC125; HIV; Etravirine; ETR; Intelence; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet

  Assessment visit (Day 1)

Study Arms (1)

001

EXPERIMENTAL

etravirine One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet

Drug: etravirine

Interventions

etravirine DRUG

One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must be postmenopausal for at least 2 years, OR be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), OR be not heterosexually active for the duration of the study or have a vasectomized partner (confirmed sterile) OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control (as specified below) before entry, and agree to continue to use a highly effective method of contraception throughout the study. Women with tubal ligation are required to use one contraceptive method (Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction)
• All women must have a negative serum or urine pregnancy test at screening. Women of childbearing potential must have a negative urine pregnancy test at other visits
• Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or non-estrogen hormonal based contraceptives) and to not donate sperm during the study
• Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
• Patient can comply with the protocol requirements

You may not qualify if:

• Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
• Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety, ability to swallow, or outcome of the trial
• Pregnant or breastfeeding female patient

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Links

• A study to survey the swallowability of non-coated 200-mg tablets of etravirine in HIV-1 infected subjects

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

etravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 22, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 11, 2012

Record last verified: 2012-12